BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXDI-55C

    MDR report key: 3301007 · Received August 15, 2013

    Report

    Report Number
    2029102-2013-00001
    Event Type
    Malfunction
    Date Received
    August 15, 2013
    Report Date
    August 15, 2013
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K091436
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED BY CANON U.S.A., INC., HEALTHCARE SOLUTIONS DIVISION. MANUFACTURER IS CANON, INC., (B)(4). SERVICE ENGINEER WAS UNABLE TO DUPLICATE THE PROBLEM. THE REF PCB WAS REPLACED. CALIBRATION AND SELF-TEST WERE PERFORMED. ALL FUNCTIONS WERE CHECKED. PANEL WAS RETURNED TO CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HORIZONTAL AND VERTICAL LINES ON THE IMAGE. IT IS POSSIBLE THAT THE IMAGE WAS RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394565 CXDI-55C MQB CANON, INC. CXDI-55C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK